The main TMDA Quality Control Laboratory at sub-head office in Dar es Salaam is subdivided into three (3) sections namely Medicines Chemical Analysis, Microbiology Analysis, and Medical Devices and Diagnostics Testing Analysis.
The laboratory is responsible for testing of medicines, medicines' raw materials, diagnostics, and medical devices products.
Medicines Analysis Laboratory is prequalified by WHO for testing of medicines since January, 2011. Microbiology laboratory is prequalified in pharmaceutical testing in November 2021. The plan to accredit the Medical Devices laboratory as per ISO/IEC 17025:2017 standard is in process.
Laboratory Quality Management System
The laboratory Quality management system office is located in the office of the laboratory Director, and is handled by laboratory Quality Officer (LQO). It oversees the implementation of Quality Management System in accordance to the requirements of ISO/IEC 17025:2017 and WHO - Good Practices for Pharmaceutical Quality Control Laboratory and other recommended standards.
The management ensure that laboratory staff are free from undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of the work.
The laboratory is equipped with ultra modern equipment that are calibrated and maintained at frequencies specified by QMS documents in order to ensure maximum run-time and produce reliable and accurate results.
Qualified and competent staff are employed and subjected to regular training as per approved training program and proficiency testing scheme for competence assessment. Dar es Salaam TMDA Quality Control Laboratory has 30 staffs with various qualifications as follows: